Orudis Kt

NDA 20429, held by Wyeth Cons. Ketoprofen.

As of Nov 13, 2026, NDA 20429 (Orudis Kt), held by Wyeth Cons, was first approved by FDA on Oct 6, 1995, with 7 approved supplements and 0 published complete response letters.

First approved: Oct 6, 1995
Review: Standard
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Oct 6, 1995	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Orudis Kt12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Ketoprofen	DiscontinuedReference drug

All 8 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Sep 10, 2004	Supplement 8Labeling · Standard review	Approved	Letter
Aug 30, 2004	Supplement 7Labeling · Standard review	Approved	Letter
Feb 20, 2002	Supplement 5Manufacturing · Standard review	Approved	None posted
Aug 23, 2000	Supplement 4Labeling · Standard review	Approved	None posted
Oct 14, 1998	Supplement 3Manufacturing · Standard review	Approved	None posted
Dec 26, 1995	Supplement 2Labeling · Standard review	Approved	None posted
Nov 3, 1995	Supplement 1Labeling · Standard review	Approved	None posted
Oct 6, 1995	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20429
Drugs@FDA: Overview at FDA
Company: Wyeth Consumer Healthcare

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters